PCT for Speech, Language, and Cognitive Intervention in Stroke Patients

Completed · Phase 2

Conditions studied: Aphasia, Acquired

In brief

Given the evolving uses of technology in rehabilitation, the investigators aimed to measure the change in aphasia severity using PCT App, a digital therapeutic adapted from Constant Therapy (CT), a dynamic, personalized therapy program for people with cognitive, speech, or language disorders. The entire study, including recruitment, enrollment, assessment and treatment were conducted remotely. The proposed pilot study seeks to compare performance of PCT therapy vs. conventional workbook intervention for stroke patients. The investigators hypothesize that the experimental (PCT) group will experience greater gains on the WAB-AQ at follow-up compared to baseline compared to a control (workbook) group. Subjects were prospectively assigned to an experimental or active control group in a random order with both groups balanced for their baseline level of speech, language and/or cognitive ability: 1. Experimental Group: Participants were instructed to use PCT for at least 30 minutes/day, 5 days/week. Performance and usage data were automatically reported by the PCT software to the treating clinician and was used to modify task assignment over time and monitor participant adherence to the treatment program. 2. Active Control Group: Participants were provided with a standard regime of paper workbooks (e.g. Workbook for Aphasia; Brubaker, 2006) that are typically used by clinicians with persons with aphasia (PWA) for at least 30 minutes/day, 5 days/week. Notably, the control procedure employed here is similar to a large-scale study examining technology as a treatment option by Palmer and colleagues (2015). The treatment period was 10 weeks. All participants received a bimonthly check-in through video-chat with a member of the research staff during the treatment period.

Key facts

Study ID: NCT04488029
Run by: The Learning Corp
People needed: 36
Starts: 2019-03-18
Expected to finish: 2020-02-20
Last updated by the study team: 2020-07-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Have diagnosis of stroke involving a hemorrhage or ischemic event, resulting in speech, language, and/or cognitive deficits
Have time post-stroke of at least 4 months prior to enrollment
Have been discharged from rehabilitation hospital
Are adults (aged 18 years or older) at the time of consent
Exhibit clinically confirmed speech, language, and/or cognitive deficits based on medical records
Are fluent English speakers
Have confirmed aphasia using the WAB-R Aphasia Quotient (score of 90 or lower; 93.8 is cutoff for normal scores)
Have a presence of a family member or caregiver who is willing and able to provide assistance during the duration of study period

You may not qualify if…

Have comorbid neurological conditions that could impair study participation in the opinion of the investigator, such as dementia or Parkinson's disease
Currently require inpatient care or acute care
Are currently undergoing related one-on-one individual therapy at a hospital, rehabilitation facility, university, or at home
Exhibit severe apraxia of speech or severe dysarthria of speech, as verified by a clinician and confirmed by the WAB-R (and the Screen for Dysarthria and Apraxia of Speech if necessary), and/or medical records
Have comorbid psychiatric conditions that could impair study participation in the opinion of the investigator, including such as schizophrenia or major depressive disorder, as indicated by medical records
Have uncorrected hearing or vision loss

Where it is running

The Learning Corp — Newton, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.